Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01401816
First received: June 21, 2011
Last updated: July 6, 2012
Last verified: June 2011
  Purpose

Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%). It has been estimated that if Emergency Contraception (Plan B) was used after every contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions annually.

Previous studies have showed the effectiveness of emergency contraception decreases with time after intercourse; the sooner it is taken—even if it means a matter of hours—the more effective it is in preventing pregnancy. Based on previous studies, it is clear that relying on obtaining emergency contraception on the same day or even the day after unprotected intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the adolescent mystery caller did not have the medication available the day of the call and almost all of the pharmacies not stocking the medication would take greater than 24 hours to obtain it through their ordering system.

Thus, the concept of advanced provision of emergency contraception has been proposed to assure that the medication can be taken as soon as possible. Although this practice is known to be safe and has not shown any association with increased sexual risk or behaviors, it is unclear how often/if adolescents will fill a prescription for a medication that is not needed at the time of a medical encounter.

The investigators propose a randomized pilot study (n=60) of a text-messaging intervention that aims to increase the rate at which prescriptions for emergency contraception are filled. Based on practice norms in the BMC Adolescent Center, sexually active female adolescents (ages 13-21) in both the control and intervention groups will be provided a prescription for emergency contraception. The intervention group, however, will receive follow-up text message on their phone reminding them to fill the prescription.

Boston Medical Center Health Plan will provide prescription fill data regarding the prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all study participants will be contacted for a follow-up survey.


Condition Intervention
Sexually Active
Other: Text Message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Prescription Fill Rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The primary outcome is whether the advanced provision prescription for emergency contraception is filled or not. This will be measured through insurance claims data obtained from BMC Health Plan a month after enrollment. Furthermore, the time to fill the prescription from the time of enrollment can be examined.


Secondary Outcome Measures:
  • Sexual Activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Each study participant will receive a follow-up telephone call to his or her personal cell phone six weeks after enrollment to complete a follow-up survey that will consist of questions related to sexual activity since enrollment.

  • Contraception Use [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Each participant will receive a follow-up telephone survey and answer questions regarding their use of contraception (if any) and how often they utilized such methods since enrollment.

  • Risk of Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Each study participant will receive a telephone survey and be asked if they have used emergency contraception (EC) since enrolling in the study or if they have taken a pregnancy test since enrolling.

  • Knowledge of Emergency Contraception [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Each study participant will receive a follow-up telephone survey and answer questions on the time-frame and accessibility of emergency contraception.


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
Subjects in this group will receive a prescription for emergency contraception and then text-messages (on Day 1, 3 and 5 after enrollment) to their personal cell phone with a reminder to fill their prescription.
Other: Text Message
Subjects will receive a text message on their personal cell phone on Days 1, 3 and 5 after enrollment reminding them to fill their prescription.
No Intervention: Control Group
Subjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sexually Active
  • Boston Medical Center Health Plan Insurance
  • Personal Cell Phone

Exclusion Criteria:

  • Pregnant
  • Currently using a long-acting form of contraception (IUD, Depo, Implanon)
  • No personal cell phone
  • Insurance other than Boston Medical Center Health Plan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401816

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael Silverstein, MD, MPH Boston Medical Center
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01401816     History of Changes
Other Study ID Numbers: Alpert 3442-3
Study First Received: June 21, 2011
Last Updated: July 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Adolescents
Sexually Active
Unprotected Sex
Emergency Contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014